Senior Specialist, Quality Assurance, CSV

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Definium Therapeutics

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51 - 200 Mitarbeiter

Gegründet 2019

🏥 Gesundheitswesen

🧬 Biotechnologie

💊 Pharmazie

Healthcare • Biotechnology • Pharmaceuticals

Definium Therapeutics ist ein biopharmazeutisches Unternehmen in der klinischen Entwicklungsphase, das präzise psychedelisch-abgeleitete Therapeutika für psychiatrische und neuroentwicklungsbedingte Störungen entwickelt. Das Unternehmen konzentriert sich auf pharmazeutisch optimierte Formulierungen von Lysergid (LSD) und ein R-Enantiomer von MDMA, um Zustände wie schwere depressive Störung, generalisierte Angststörung und Kernsymptome von Autismus-Spektrum-Störung zu behandeln. Es treibt die Kandidaten mit einem wissenschaftlich fundierten, evidenzbasierten Ansatz durch präklinische und klinische Studien voran.

Beschreibung

• Partner cross-functionally with IT and the business to implement and maintain compliant computerized systems • Provide quality oversight for the lifecycle of computerized systems, ensuring compliance with GAMP 5, 21 CFR Part 11, and Data Integrity standards • Serve as the QA CSV SME during vendor evaluations, software implementation and qualification and requalification of GxP systems • Support continuous improvement of GxP Systems through SOP development, training, and change control management • Partner with IT and Business teams to ensure SDLC and validation requirements are clearly defined and met • Lead investigations for CSV-related deviations, system failures, and data integrity issues, including root cause analysis • Review and approve Computer System Validation (CSV) documentation including Validation Plans, IQ/OQ/PQ protocols, and summary reports • Advise on data integrity best practices and approaches • Partner with IT to ensure inspection readiness is maintained for CSV • Serve as QA reviewer for all new system releases and change controls • Perform internal audits to ensure systems are maintained in a steady state and user management is under control • Ensure adherence to regulatory and quality standards throughout the software development lifecycle • Support systems and new product introduction by providing QA expertise, problem solving, and strategies for risk mitigation • Support validation and QA oversight of AI/ML-enabled GxP systems, including risk assessment for model changes and ongoing performance monitoring

🎯 Anforderungen

• 7+ years experience working in the pharmaceutical/biotech space required • 5+ years’ experience with CSV validation lifecycle management • Bachelor’s degree in a life science field • Excellent understanding of 21 CFR Part 11/Annex 11 compliance and Computer System Validation (CSV), Computer System Assurance (CSA), IT SLDC best practices, General Data Protection Regulation (GDPR) regulations, and GAMP 5 Guidance • Proven experience in assisting validation efforts for SaaS/PaaS GxP systems • Broad understanding of Technology implementation (SaaS) and Data migrations approaches • Experience validating or assessing AI/ML-based systems in a regulated environment, including understanding of model risk and change control considerations • Demonstrated experience in reviewing key validation deliverables such as user requirements, validation plans, validation reports and test scripts

🏖️ Vorteile

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents • 401(k) program with company match and vesting after the turn of the first month after your start date • Flexible time off • Generous parental leave and some fun fringe perks!